BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233539 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06146
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION. CONTINUED PULSATILE BLEEDING CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, PATIENT'S ANATOMICAL CONDITIONS AND/OR USER TECHNIQUE. THE ARTERY OF THE PATIENT WAS DESCRIBED AS HAVING SOME CALCIFICATION. THE PROGLIDE INSTRUCTIONS FOR USE STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. A CONCLUSIVE CAUSE FOR THE REPORTED CONTINUED PULSATILE BLEEDING COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE WERE NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEW OF THE EVENT INFORMATION AND MANUFACTURING TESTING/INSPECTION CRITERIA, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (DATE OF EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED APPROXIMATELY 3 WEEKS PRIOR FROM THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2011 IS BEING USED AS THE BEST ESTIMATED DATE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW WILL NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY, DESCRIBED WITH SOME CALCIFICATION, AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, DURING KNOT ADVANCEMENT PULSATILE BLEEDING CONTINUED, THE SUTURES WERE REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. A 6 FR. SHEATH WAS USED DURING VESSEL CLOSURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 FR. OTHER: ANGIOMAX.